BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK DSP

    MDR report key: 1043219 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33412
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 12, 2008
    Report Date
    March 12, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z1144/1145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK DSP IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0125 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other THE DEVICE 438-/30745M WAS IMPLANTED 03-JUN-1999| THE DEVICE T135/936301 WAS IMPLANTED 14-JUN-2004